Life Science News

JUVÉDERM ® VOLUX™ XC IS THE FIRST AND ONLY HYALURONIC ACID (HA) FILLER TO RECEIVE U.S. FDA APPROVAL FOR IMPROVING JAWLINE DEFINITION

Today, Allergan Aesthetics, an ABBVie company (NYSE: ABBV), announced the U.S. FDA approval of JUVÉDERM ® VOLUX™ XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition. 1

JUVÉDERM® VOLUX™ XC Packaging

"The approval of JUVÉDERM ® VOLUX™ XC represents the largest leap in innovation for our U.S. HA portfolio since the introduction of JUVÉDERM ® VOLUMA ® XC, 2 " said Carrie Strom , President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "JUVÉDERM ® VOLUX™ XC complements our existing product line to provide even more structure, cohesivity and lift capacity to create an improved jawline that appears more defined in real life and on camera. JUVÉDERM ® VOLUX™ XC is what our providers have been asking for to deliver the jaw-dropping results their patients are seeking. 1 "

As the category leader, the JUVÉDERM ® Collection of Fillers offers the broadest portfolio of specifically designed treatment options, and this latest approval of JUVÉDERM ® VOLUX™ XC marks the sixth product offering in the lineup alongside JUVÉDERM ® VOLUMA ® XC, JUVÉDERM ® VOLLURE ® XC, JUVÉDERM ® Ultra Plus XC, JUVÉDERM ® Ultra XC, and JUVÉDERM ® VOLBELLA ® XC. 1-3,5-7

In the pivotal clinical study, JUVÉDERM ® VOLUX™ XC was found to effectively improve jawline definition (69.9%, 102/146) at six months. Participants reported satisfaction using the Satisfaction with Lower Face and Jawline module of the FACE-Q questionnaire, most treatment group participants (82.3%, 116/141) reported satisfaction with the appearance of their lower face and jawline through 12 months following treatment with JUVÉDERM ® VOLUX™ XC. 4 Additionally, 81.5% (119/146) of participants at six months were satisfied with how sculpted (well-defined) their jawline looked compared to 12.2% (19/156) at baseline. At six months, 70.5% (103/146) of participants were satisfied with how smooth their lower face looked (i.e., no jowls or folds of fatty skin) compared to 7.7% (12/156) at baseline and 73.1% (106/145) of participants at six months were satisfied with how nice their lower face looked compared to 9.0% (14/156) at baseline. 4

"Requests for treatment in the lower facial region transcend age, gender, race, and ethnicity in my practice. As people age, many factors can contribute to how the lower face changes, such as genetics and soft tissue loss," says Dr. Jeremy Green , a fellowship-trained board-certified Miami cosmetic dermatologist and pivotal clinical trial investigator. "This can cause reduced definition around the jawline area that may impact and change the shape of the face and lead to the appearance of jowls. Clinical trial participants reported high satisfaction with the results of their treatment. In fact, at six months post-treatment, 89.7% (131/146) of treatment group participants were willing to recommend the treatment to a friend, with the majority continuing to recommend treatment at 12 months (87.2%, 123/141). 4 I am excited to now be able to offer this treatment option to all of my patients seeking an improved jawline."

Commonly reported side effects in the clinical study included tenderness, lumps/bumps, pain, swelling, firmness, bruising, redness, itching, and discoloration at the injection sites, as reported in participants' 30-day daily diaries. These side effects are consistent with HA filler injection and were usually mild (causing little discomfort and no effect on daily activities) or moderate (causing some discomfort and effect on daily activities) in severity. Most of these side effects went away on their own within two weeks. Participants also reported similar side effects after maintenance injection. 1

Allergan Aesthetics is dedicated to training health care providers on safe and effective use of all its products. Allergan Medical Institute will be providing an in-depth product training program for JUVÉDERM ® VOLUX™ XC, which will include facial anatomy, considerations for safe injection in this area, appropriate patient selection, and aseptic technique. Training will begin in fall of 2022. JUVÉDERM ® VOLUX™ XC will be more broadly available to consumers in early 2023.

For more information on the JUVÉDERM ® Collection of Fillers, visit Juvederm.com and follow @JUVÉDERM on Instagram.

Consumers and new patients who receive an aesthetic treatment with a product from the JUVÉDERM ® Collection of Fillers can also enroll in Allē, Allergan Aesthetics' loyalty rewards program. Consumers can enroll to unlock access to curated content, exclusive offers, and personalized rewards that can be used for savings on the Allergan Aesthetics portfolio of products and redeemed at a participating provider's office, subject to applicable program terms and conditions. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 40 non-Allergan Aesthetics treatments and brands. To learn more about Allē, visit Alle.com.

About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com .

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

JUVÉDERM ® Injectable Gel Fillers Important Information

APPROVED USES

JUVÉDERM ® VOLUX™ XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.

JUVÉDERM ® VOLUMA ® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.

JUVÉDERM ® VOLLURE ® XC, JUVÉDERM ® Ultra Plus XC, and JUVÉDERM ® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM ® VOLLURE ® XC injectable gel is for adults over 21.

JUVÉDERM ® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.

JUVÉDERM ® VOLBELLA ® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive any JUVÉDERM ® formulation?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.

What warnings should my doctor advise me about?

  • One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.
  • The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
  • The effectiveness of removal of any dermal filler has not been studied.

What precautions should my doctor advise me about?

  • JUVÉDERM ® VOLBELLA ® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist . Doctors who complete the training will be listed with a symbol
  • The safety of these products for use during pregnancy or while breastfeeding has not been studied
  • The safety of JUVÉDERM ® VOLUMA ® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM ® VOLUX™ XC, JUVÉDERM ® VOLLURE ® XC and JUVÉDERM ® VOLBELLA ® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM ® Ultra XC has not been studied in patients under 18 years
  • The safety and effectiveness of treatment with JUVÉDERM ® products in anatomical regions outside of their approved uses have not been established in clinical studies
  • If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
  • If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM ® injectable gel treatment
  • Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site
  • Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
  • JUVÉDERM ® VOLUMA ® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
  • The effect of JUVÉDERM ® VOLUMA ® XC injection into the chin on facial hair growth has not been studied
  • Patients who experience skin injury near the site of JUVÉDERM ® VOLUMA ® XC injection may be at a higher risk for adverse events
  • Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment

What are possible side effects of treatment?
The most commonly reported side effects with JUVÉDERM ® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM ® VOLBELLA ® XC, dryness was also reported.

These side effects are consistent with other facial injection procedures, and most will resolve with time. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).

As with all skin injection procedures, there is a risk of infection.

To report a side effect with any product in the JUVÉDERM ® Collection, please call the Allergan ® Product Support Department at 1‑877‑345‑5372. Please also visit Juvederm.com or talk to your doctor for more information.

Products in the JUVÉDERM ® Collection are available only by a licensed physician or properly licensed practitioner.

References

  1. Allergan Data On File JUVÉDERM ® VOLUX™ XC Patient Label 2022
  2. Allergan Data On File JUVÉDERM ® VOLUMA ® XC Patient Label 2020
  3. Allergan Data On File JUVÉDERM ® VOLBELLA ® XC Patient Label 2020
  4. Allergan Data On File JUVÉDERM ® VOLUX™ XC Directions For Use 2022
  5. Allergan Data On File JUVÉDERM ® VOLLURE ® XC Patient Label 2020
  6. Allergan Data On File JUVÉDERM ® Ultra Plus XC Patient Label 2020
  7. Allergan Data On File JUVÉDERM ® Ultra XC Patient Label 2020

Actual JUVÉDERM® VOLUX™ XC Patients

JUVÉDERM® VOLUX™ XC Logo

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SOURCE AbbVie

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ABBV
Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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Bristol Myers Squibb and Turning Point Therapeutics Announce Expiration of HSR Act Waiting Period and Clearance from Federal Cartel Office of Germany Related to Pending Acquisition of Turning Point Therapeutics

Bristol Myers Squibb (NYSE:BMY) and Turning Point Therapeutics, Inc. (NASDAQ:TPTX) ("Turning Point") today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR Act"), and the receipt of merger control clearance from the Federal Cartel Office of Germany ("FCO"), in connection with the previously announced offer (the "Offer") to acquire all outstanding shares of common stock of Turning Point at a price of $76.00 per share in an all-cash transaction for total consideration of approximately $4.1 billion. The expiration of the HSR Act waiting period occurred at 11:59 p.m. Eastern Time on August 15, 2022, and the FCO clearance was received on August 15, 2022. The Offer expired at 5:00 p.m. Eastern Time on August 15, 2022 (the "Expiration Time"), and the Offer was not extended.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220816005404/en/

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Gilead to Acquire Remaining Worldwide Rights of Trodelvy®

Gilead will Assume Responsibility for Clinical Development and Commercialization in Greater China and South Korea, among Other Asian Markets –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement with Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy ® (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia.

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Trodelvy® Significantly Improves Overall Survival in Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients in the TROPiCS-02 Study

Trodelvy is the First TROP-2 Directed ADC to Show a Significant Improvement in Overall Survival in HR+HER2- Breast Cancer –

Planned Second Interim Analysis Demonstrated a Statistically Significant and Clinically Meaningful Benefit for Overall Survival

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The Gummy Project Announces Launch of New Investor Relations Website

The Gummy Project Announces Launch of New Investor Relations Website

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company")  is pleased to announce the launch of its new investor relations website at https:shopgummies.compagesinvestors.

The investor relations website features excellent functionality and streamlined access to essential investor information, including recent company press releases, sector information and more.

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bowl with healthy food on it alongside an avocado and cutlery

Hungry for Change: Investing in the Plant-based Food Industry

Animal agriculture is one of the top five sources of greenhouse gas emissions, much of which is directly attributable to livestock. It's been estimated by the United Nations, for instance, that the livestock sector represents approximately 14.5 percent of all global greenhouse gas emissions. Given the current international push for sustainability, this is a problem — and people are demanding a solution.

Driven by concerns about health, climate change and animal welfare, consumers are demandingethical and sustainable alternatives to meat, dairy, fish, and poultry. Nearly two-thirds (63 percent) of respondents to a survey on flexitarian diets would swap to plant-based alternatives because they're more ethical.

Unsurprisingly, this demand represents a considerable opportunity for anyone interested in sustainable investing. According to Bloomberg Intelligence, the global plant-based food market is expected to reach a total value of US$162 billion by 2030. A survey from the Food Institute shows that 79 percent of Americans from Generation Z choose meatless options at least once or twice a week.

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BELLUS Health Reports Second Quarter 2022 Financial Results and Business Highlights

- Completed positive End-of-Phase 2 meeting with the Food and Drug Administration ("FDA") and received scientific advice from the European Medicines Agency ("EMA") to support design of its CALM Phase 3 program, which is expected to initiate in Q4 2022 -

- Ended second quarter 2022 with approximately US$384.6 million in pro-forma cash, cash equivalents and short-term investments, including net proceeds from the July 2022 financing; Cash runway extended to 2H 2025 and through the topline results of both CALM-1 and CALM-2 trials -

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