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The Daily Biotech Pulse: Pfizer-BioNTech Preps For BLA Filing, Sonoma Surges, BioXcel Readout, Ortho Clinical Lands Contract

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The Daily Biotech Pulse: Pfizer-BioNTech Preps For BLA Filing, Sonoma Surges, BioXcel Readout, Ortho Clinical Lands Contract

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 March 31)

  • AngioDynamics, Inc. (NYSE: ANGO)
  • Axonics Modulation Technologies, Inc. (NYSE: AXNX)
  • Gain Therapeutics, Inc. (NASDAQ: GANX)
  • Laboratory Corporation of America Holdings (NYSE: LH)
  • Lava Therapeutics B.V. (NASDAQ: LVTX)
  • Merit Medical Systems, Inc. (NASDAQ: MMSI)
  • PPD, Inc. (NASDAQ: PPD)
  • Surmodics, Inc. (NASDAQ: SRDX)
  • Varian Medical Systems, Inc. (NYSE: VAR)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 31)

  • Biophytis SA (NASDAQ: BPTS)
  • Metacrine, Inc. (NASDAQ: MTCR)
  • Nanobiotix S.A. (NASDAQ: NBTX)
  • Vaxcyte, Inc. (NASDAQ: PCVX)

Stocks In Focus

Sonoma Strikes Deal to Distribute Dermatology and Eye and Wound Care Products In U.S.

Sonoma Pharmaceuticals, Inc. (NASDAQ: SNOA) announced an agreement with EMC Pharma, giving the latter the exclusive right to distribute its HOCl-based prescription dermatology and eye care products in the U.S. for an initial term of five years, subject to extension.

EMC Pharma will also have a non-exclusive agreement to distribute certain Microcyn-based wound care products into government channels.

As part of the agreement, EMC will acquire all of the existing inventory and pay a royalty and transfer prices over the initial five-year term. The parties also agreed on certain minimum purchase requirements to maintain exclusivity of the distribution rights.

In after-hours trading, the stock gained 24.23% to $9.23.

BioXcel Reports Mixed Results For Phase 1b/2 Study of Drug to Treat Opioid Withdrawal Symptoms

BioXcel Therapeutics, Inc. (NASDAQ: BTAI) announced positive topline results from the Phase 1b/2 proof-of-concept study of its investigational asset BXCL501 that is being evaluated for the treatment of opioid withdrawal symptoms.

The company said the study met its primary safety endpoint across multiple doses given twice-daily over seven days. BXCL501 was generally well tolerated, with no severe or serious adverse events reported, and dose dependent exposures were observed across all doses evaluated, it added.

However, the secondary endpoint of retention was not met with statistical significance.

The stock slipped 7.78% to $39.80 in after-hours trading.

Opiant Gets Final Tranche of $1.8 Million Award For Study of Opioid Overdose Drug

Opiant Pharmaceuticals, Inc. (NASDAQ: OPNT) said it has been has received the third and final tranche of $1.8 million from the total grant of approximately $7.4 million from the National Institute on Drug Abuse, part of the National Institutes of Health, to support the development of OPNT003, nasal nalmefene, for the treatment of opioid overdose.

Ortho Clinical Diagnostics Gets $53.7M Contract For COVID-19 Testing Solutions

In-vitro diagnostics company Ortho Clinical Diagnostics (Nasdaq: OCDX) said it has been awarded an undefinitized contract by the BARDA and the U.S. Department of Defense, which will lead to a $53.7 million award to support a more than three-fold increase in domestic production capabilities for its COVID-19 serological and diagnostic testing solutions.

The new contract, the company said, will deliver funding for capacity expansion to provide up to 6.7 million COVID-19 tests per month dedicated for the U.S. market by the second quarter of 2022.

The stock gained 4.95% to $20.25 in after-hours trading.

Rhythm Rises On Insider Buying

Rhythm Pharmaceuticals, Inc. (NASDAQ: RYTM) shares gained ground after the company revealed in a filing its CEO David Meeker bought 10,000 shares in the company for $20.1713 per share.

The stock added 5.55% to $22.45 in after-hours trading.

Atreca's Chief Scientific Officer Norman Greenberg Quits

Atreca, Inc. (NASDAQ: BCEL) said in a filing its chief scientific officer Norman Greenberg has resigned, effective March 31, to pursue a new business opportunity. The company clarified that Greenberg's departure was not due to any disagreement with the company or any matters relating to its operations, policies or practices.

In after-hours trading, the stock slipped 6.98% to $14.26.

Pfizer, BioNTech Announces Positive Efficacy, Safety Data Through 6 Months Following Second COVID-19 vaccine dose

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, showing that the COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose. The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective against severe COVID-19 as defined by the FDA.

"These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA," said Albert Bourla, CEO of Pfizer.

BD, Abbott, Quidel Gets Emergency Use Authorizations For COVID-19 Tests

Becton, Dickinson and Company (NYSE: BDX) announced FDA has granted emergency use authorization for its rapid antigen test to be used for SARS-CoV-2 screening through serial testing of asymptomatic individuals.

Quidel Corporation (NASDAQ: QDEL) received emergency use authorization for its at-home over-the-counter COVID-19 test.
Abbott (NYSE: ABT) received emergency use nod for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW COVID-19 Ag self-test for detection of COVID-19 infection.

Sanofi Gets FDA Approval For Blood Cancer Combo Treatment In Second-line Settings And Above

Sanofi SA's (NASDAQ: SNY) Sarclisa, in combination with carfilzomib and dexamethasone, was approved by the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received one to three prior lines of therapy.

""With this approval, Sarclisa is now included in two standard of care regimens for the treatment of patients with multiple myeloma as early as first relapse. Today's milestone further supports our ambition for Sarclisa to become the anti-CD38 of choice for patients with relapsed or refractory multiple myeloma," said Peter Adamson, Global Development Head, Oncology and Pediatric Innovation at Sanofi.

Offerings

Applied Molecular Transport Inc. (NASDAQ: AMTI) priced an underwritten public offering of 2.5 million shares of its common stock at a price of $42 per share, for raising gross proceeds of about $105 million. All of the shares of common stock are being offered by AMT. The offering is expected to close on April 6, 2021, subject to the satisfaction of customary closing conditions.

The stock ended after-hours trading 0.82% lower at $43.65.

CTI BioPharma Corp. (NASDAQ: CTIC) priced its previously announced underwritten public offering of 14.26 million shares of its common stock at $2.50 per share. The pricing of 600 shares of its series X preferred stock was set at $25,000. Each share of Series X preferred will be convertible into 10,000 shares of common stock at the election of the holder.

The stock fell 10.65% to $2.60 in after-hours trading.

On The Radar

Earnings

Milestone Scientific Inc. (NYSE: MLSS) (after the close)

 

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