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The Daily Biotech Pulse: Amgen Earnings, GSK-CureVac Vaccine Collaboration, Mallinckrodt FDA Decision

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The Daily Biotech Pulse: Amgen Earnings, GSK-CureVac Vaccine Collaboration, Mallinckrodt FDA Decision

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 Feb. 2)

  • Argenx SE – ADR (NASDAQ: ARGX)
  • Aslan Pharmaceuticals Ltd (NASDAQ: ASLN)
  • Atea Pharmaceuticals Inc (NASDAQ: AVIR)
  • AtriCure Inc. (NASDAQ: ATRC)
  • BIO-TECHNE Corp (NASDAQ: TECH) (announced second-quarter results)
  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX)
  • C4 Therapeutics Inc (NASDAQ: CCCC)
  • Cassava Sciences Inc (NASDAQ: SAVA) (reacted to positive data readout for Alzheimer's drug)
  • Catalent Inc (NYSE: CTLT) (announced its second-quarter results)
  • CorMedix Inc. Common Stock (NASDAQ: CRMD) (shares were uplisted to Nasdaq)
  • DarioHealth Corp (NASDAQ: DRIO)
  • Endo International PLC (NASDAQ: ENDP)
  • Frequency Therapeutics Inc (NASDAQ: FREQ)
  • G1 Therapeutics Inc (NASDAQ: GTHX)
  • Glaukos Corp (NYSE: GKOS)
  • Haemonetics Corporation (NYSE: HAE) (reacted to its third quarter results)
  • Harvard Bioscience, Inc. (NASDAQ: HBIO)
  • Hologic, Inc. (NASDAQ: HOLX) (announced a partnership with Alphabet Inc's Class A (NASDAQ: GOOGL)for cervical cancer screening)
  • Immunome Inc (NASDAQ: IMNM)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX)
  • Maravai Lifesciences Holdings Inc (NASDAQ: MRVI)
  • Morphic Holding Inc (NASDAQ: MORF)
  • Nantkwest Inc (NASDAQ: NK)
  • Ocugen Inc (NASDAQ: OCGN)(announced U.S. coronavirus manufacturing deal with India's Bharat Biotech)
  • Oramed Pharmaceuticals, Inc. (NASDAQ: ORMP)
  • Organogenesis Holdings Inc (NASDAQ: ORGO)
  • Profound Medical Corp (NASDAQ: PROF)
  • Silence Therapeutics ADR (NASDAQ: SLN)
  • Vaxart Inc (NASDAQ: VXRT)
  • Veracyte Inc (NASDAQ: VCYT)
  • Vericel Corp (NASDAQ: VCEL)
  • Vincerx Pharma Inc (NASDAQ: VINC)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Feb. 2)

  • Avidity Biosciences Inc (NASDAQ: RNA)
  • NLS Pharmaceutics AG (NASDAQ: NLSP) (IPOed Friday)

Stocks In Focus

Affimed to Study AFM24 In Combination With Roche's Tecentriq For Cancer

Affimed NV (NASDAQ: AFMD) said it has entered into a clinical research collaboration with Roche Holdings AG (OTC: RHHBY) to explore the combination of Affimed's innate cell engager AFM24 with Roche's PD-L1 checkpoint inhibitor Tecentriq.

As per the agreement, Affimed will fund and conduct a Phase 1/2a clinical trial to investigate the combination for the treatment of advanced solid epidermal growth factor receptor expressing malignancies in patients whose disease has progressed after treatment with previous anticancer therapies. Roche will supply Affimed with Tecentriq for the clinical trial.

The Phase 1/2a study, according to Affimed, will establish a dosing regimen for the combination therapy and assess safety and potential activity.

Affimed shares were rallying 12.34% to $6.60 in premarket trading Wednesday.

Amgen Drops On Lackluster FY21 Guidance

Amgen, Inc. (NASDAQ: AMGN) reported a 7% year-over-year increase in fourth-quarter revenues to $6.6 billion, and non-GAAP EPS rose by 5% to $3.81, ahead of the $3.39 per share consensus estimate. For 2021, the company expects revenues of $25.8 billion to $26.6 billion and non-GAAP EPS of $16-$17. Analysts, on average, estimate revenues of $26.43 billion and non-GAAP EPS of $17.03.

The stock moved down 1.58% to $236.69 in after-hours trading.

GSK, CureVac to Collaborate to Develop Next-gen COVID-19 mRNA Vaccine

GlaxoSmithKline plc (NYSE: GSK) and CureVac BV (NASDAQ: CVAC) announced a new150-million-euro ($180.6 million) collaboration to jointly develop next generation mRNA vaccines for COVID-19, with the potential for a multi-valent approach to address multiple emerging variants in one vaccine.

The development program will begin immediately, with the target of introducing the vaccine in 2022, subject to regulatory approval, the companies said.

GSK will also support the manufacture of up to 100 million doses of CureVac's first generation COVID-19 vaccine candidate CVnCoV in 2021.

CureVac was advancing 6.38% to $105 in premarket trading Wednesday.

Voyager, Neurocrine To Terminate Parkinson's Drug Collaboration

Voyager Therapeutics Inc (NASDAQ: VYGR) said Neurocrine Biosciences, Inc. (NASDAQ: NBIX) has served the notice of termination of the Parkinson's disease portion of the collaboration agreement, effective August 2, 2021.

The decision may have to do with Neurocrine's portfolio review and prioritization of its current pipeline assets, Voyager said.

The Friedreich's ataxia program and two discovery programs that are also part of the agreement are not impacted and remain under active collaboration, it added.

The stock lost 12.50% to $7 in after-hours trading.

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

Novo Nordisk FY20 Sales, Profit Rise

Novo Nordisk A/S' (NYSE: NVO) fiscal-year 2020 net sales rose 4% to 126.9 billion Danish Kroner ($20.54 billion), and net profit climbed 10% to 42.14 billion Danish Kroner. For fiscal year 2021, the company expects sales growth of 5-9% at constant exchange rate and operating profit growth of 4-8%.

Selecta Biosciences Gains on Disclosure of Fund Stake

Selecta Biosciences Inc (NASDAQ: SELB) shares rallied after a SEC filing revealed that BlackRock, Inc. (NYSE: BLK) held about 5.47 million shares or a 5.1% stake in the company.

The stock gained 19.64% to $5.30 in after-hours trading.

BioCryst Gets Label Expansion For Influenza Drug

BioCryst announced FDA approval for supplemental new drug application for Rapivab, peramivir injection, which expands the patient population of the compound for the treatment of acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, Rapivab had been indicated for patients two years and older.

The stock was up 7.88% to $11.36 in premarket trading Wednesday.

Sio Gene Begins Clinical Study of Gene Therapy to Treat GM2 Gangliosidosis

Sio Gene Therapies Inc (NASDAQ: SIOX) said the first patient with infantile Tay-Sachs disease has been dosed in a Phase 1/2 trial evaluating AXO-AAV-GM2, an investigational gene therapy for the treatment of GM2 gangliosidosis, also known as Tay-Sachs or Sandhoff disease.

In premarket trading Wednesday, the stock was adding 4.32% to $2.90.

Bristol-Myers Squibb Licenses COVID-19 Antibody Combo From Rockfeller University

Bristol-Myers Squibb Co (NYSE: BMY) announced an agreement under which it has been granted a global exclusive license to develop, manufacture and commercialize Rockefeller University's novel monoclonal antibody duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19.

Phase 1 clinical trials to assess dosing for intravenous and subcutaneous formulations, and to assess safety for the mAb duo, were initiated by Rockefeller in mid-January. It is planned to move the combo rapidly to a registrational program following readout of the phase 1 study taking place at Rockefeller University Hospital.

Offerings

Moleculin Biotech Inc (NASDAQ: MBRX) said it intends to sell shares of common stock (or pre-funded warrants in lieu thereof) in an underwritten public offering. All shares of common stock (or pre-funded warrants in lieu thereof) in the offering will be sold by the company.

The stock was down 14.71% to $5.45 in after-hours trading.

Krystal Biotech Inc (NASDAQ: KRYS) said it has priced the previously announced underwritten public offering of 1.923 million shares of its common stock, at a public offering price of $65 per share. The gross proceeds from this offering are expected to be about $125 million. The offering is expected to close on or about Feb. 5.

In after-hours trading, the stock slipped 4.57% to $67.69.

On The Radar

PDUFA Dates

The FDA will decide on Mallinckrodt PLC ‘s (OTC: MNKKQ) BLA for StrataGraft, an engineered, bilayer tissue, designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft is being evaluated as a treatment option for deep partial-thickness thermal burns.

Earnings:

AbbVie Inc (NYSE: ABBV) (before the market open)
Biogen Inc (NASDAQ: BIIB) (before the market open)
Ligand Pharmaceuticals Inc. (NASDAQ: LGND) (before the market open)
Boston Scientific Corporation (NYSE: BSX) (before the market open)
Cardiovascular Systems Inc (NASDAQ: CSII) (after the market close)

 

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Posted-In: Biotech Earnings News Penny Stocks Guidance Offerings Small Cap FDA Best of Benzinga

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