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The Daily Biotech Pulse: Negative Regulatory Tidings For Provention Bio, Celcuity Soars On In-licensing Deal, 2 IPOs

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The Daily Biotech Pulse: Negative Regulatory Tidings For Provention Bio, Celcuity Soars On In-licensing Deal, 2 IPOs

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs April 8)

  • Aclaris Therapeutics, Inc. (NASDAQ: ACRS)
  • Oncolytics Biotech Inc. (NASDAQ: ONCY)
  • Organogenesis Holdings Inc. (NASDAQ: ORGO)
  • PRA Health Sciences, Inc. (NASDAQ: PRAH) (Germany's MERCK Kommanditgesellschaft auf Aktien (OTC: MKKGY) opted to use PRA Health's remote patient monitoring platform)
  • Vericel Corporation (NASDAQ: VCEL)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 8)

  • Achilles Therapeutics plc (NASDAQ: ACHL)
  • Adagene Inc. (NASDAQ: ADAG)
  • Axsome Therapeutics, Inc. (NASDAQ: AXSM)
  • Bellerophon Therapeutics, Inc. (NASDAQ: BLPH)
  • Concert Pharmaceuticals, Inc. (NASDAQ: CNCE)
  • FibroGen, Inc. (NASDAQ: FGEN)
  • Homology Medicines, Inc. (NASDAQ: FIXX)
  • Ikena Oncology, Inc. (NASDAQ: IKNA)
  • Immunocore Holdings plc (NASDAQ: IMCR)
  • Instil Bio, Inc. (NASDAQ: TIL)
  • Lucira Health, Inc. (NASDAQ: LHDX)
  • Metacrine, Inc. (NASDAQ: MTCR)
  • NeuBase Therapeutics, Inc. (NASDAQ: NBSE)
  • Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH)

Stocks In Focus

Provention Bio Diabetes Drug Review Likely to Be Delayed as FDA Identifies Deficiencies In Application
Provention Bio, Inc. (
Nasdaq: PRVB), said it has been notified by the FDA that it has identified deficiencies in the company's biologic license application for teplizumab for the delay or prevention of clinical type 1 diabetes. The identified deficiencies preclude discussion of labeling and post-marketing requirements/commitments at this time, the company said, citing the FDA.

 

Additionally, the FDA indicated in an informal discussion with the company regarding the May 27 Adcom meeting that pharmacokinetic profiles of teplizumab and Eli Lilly and Company (NYSE: LLY)'s product – the two drugs evaluated in the pharmacokinetic/pharmacodynamic bridging study - were not comparable and that additional data would be required before the FDA's considerations could be satisfied.

Provention Bio plunged 38.06% to $6.03 in after-hours trading.

Syndax' Monoclonal Antibody Gets Orphan Drug Designation In Fibrosis of Lungs

Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) said the FDA has granted orphan drug designation to axatilimab, its anti-CSF-1R monoclonal antibody, for the treatment of patients with idiopathic pulmonary fibrosis.

TherapeuticsMD Announces U.K. and Belgian Regulatory Approvals For Hormone Replacement Therapy to Treat Vasomotor Symptoms In Menopausal Women

TherapeuticsMD, Inc. (NASDAQ: TXMD) and women's health company Theramex announced that Bijuve has received approval from the Medicines and Healthcare products Regulatory Agency for use in the U.K. and, from the Federal Agency for Medicines and Health Products for use in Belgium. The brand name for the drug in the U.K. and Belgium will be Bijuva.

Bijuva is the first and only oral combined hormone replacement therapy with bio-identical hormones, indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.

In after-hours trading, the stock rose 4.55% to $1.38.

Greenwich Presents Positive 5-Year Immune Response Data For Breast Cancer Immunotherapy

Greenwich LifeSciences, Inc. (NASDAQ: GLSI) said final 5-year immune response data from the Phase 2b study of its immunotherapy candidate GP2, presented as an abstract published at the American Association for Cancer Research annual meeting, showed no recurrences of breast cancer over five years of follow up,

The stock was rallying 15.84% to $58.50 in premarket trading Friday.

Celcuity In-licenses Breast Cancer Drug From Pfizer, Plans to Initiate Phase 2/3 Study of the Drug Following Positive Phase 1b Readout

Celcuity Inc (NASDAQ: CELC) announced a global licensing agreement with Pfizer Inc (NYSE: PFE), granting Celcuity exclusive rights to Pfizer's gedatolisib, a Phase 1b pan-PI3K/mTOR inhibitor.

For in-licensing the asset, Celcuity paid an upfront license fee of $5 million of cash and $5 million of Celcuity's common stock. Pfizer is eligible to receive up to $330 million of development and sales-based milestone payments and tiered royalties on potential sales.

Separately, Celcuity reported positive preliminary data for the 103 patients enrolled in the expansion portion of an ongoing Phase 1b clinical trial evaluating gedatolisib, plus Ibrance and endocrine therapy, in ER+/HER2- advanced or metastatic breast cancer patients.

As of the January 11 data cut-off date, 53 of the 88 evaluable patients, or 60% had an objective response. Gedatolisib was also generally well tolerated, with the majority of treatment-related adverse events being Grade 1 or 2.

Following the encouraging results, Celcuity said it plans to initiate a Phase 2/3 study in the first half of 2022.

Celcuity shares jumped 49.90% to $21.45 in after-hours trading.

Lucira's COVID-19 Test Kit Can Identify Viral Variants

Lucira confirmed it can successfully identify the double mutant variant of COVID-19 with its Lucira molecular test kit.

The shares were rallying 15.81% to $9.67 in premarket trading Friday.

KemPharm Announces Amendment In Licensing Term For Product Candidates

KemPharm, Inc. (NASDAQ: KMPH) announced an amendment to the definitive collaboration and license agreement with an affiliate of Gurnet Point Capital, providing for an exclusive worldwide license to develop, manufacture and commercialize KemPharm's product candidates containing serdexmethylphenidate and d-methylphenidate, including Azstarys, a once-daily product for the treatment of attention deficit hyperactivity disorder in patients age six years and older.

Under the terms of the amended agreement, KemPharm is now eligible to receive a total of up to $590 million in future regulatory and sales milestone payments for Azstarys, as well as tiered royalty payments on a product-by-product basis for net sales. The original terms called for payment of up to $468 million in regulatory and sales milestones.

Potential sales milestones available under the amended agreement total $550 million, as compared to $420 million in the original agreement.
The company also said Azstarys will be commercially available in the U.S. as early as the second half of 2021.

Azstarys was approved by the FDA in early March.

Offerings

Vascular Biogenics Ltd. (NASDAQ: VBLT) announced it intends to sell ordinary shares and, to certain investors in lieu thereof, pre-funded warrants to purchase ordinary shares in an underwritten public offering. All of the securities in the offering are to be sold by the company.

The stock slipped 5.76% to $1.80 in after-hours trading.

On The Radar

IPOs

VectivBio Holding AG, a clinical stage biopharmaceutical company focused on the development of innovative treatments for severe rare conditions, priced its initial public offering of 7.5 million ordinary shares at a price of $17 per share, at the middle of the estimated price range of $16-$18. The gross proceeds to Vectiv, are expected to be $127.5 million.

Vectiv's shares are expected to begin trading on the Nasdaq under the ticker symbol VECT.

Reneo Pharmaceuticals, Inc., a clinical-stage pharma focused on the development and commercialization of therapies for patients with rare, genetic, mitochondrial diseases, priced its IPO of 6.25 million shares of its common stock at a public offering price of $15 per share, for total gross proceeds of approximately $93.8 million. The company had earlier estimated a price range of $15-$17.

The shares are expected to begin trading on the Nasdaq under the symbol RPHM.

Related Link: Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

 

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