The Daily Biotech Pulse: Moderna Coronavirus Vaccine Receives Third Regulatory Nod, Gritstone Rallies On Hedge Fund Stake, aTyr's COVID-19 Drug Data

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 Jan. 4)

ABIOMED, Inc. ABMD
Arvinas Inc ARVN
Atea Pharmaceuticals, Inc. AVIR
Bioanalytical Systems, Inc. BASI
BioNano Genomics Inc BNGO (said its subsidiary Lineagen's genetic tests identified novel variants in known autism risk genes)
BridgeBio Pharma Inc BBIO
Clearpoint Neuro Inc CLPT
Curis, Inc. CRIS
DiaMedica Therapeutics Inc DMAC
Eidos Therapeutics Inc EIDX (proxy advisory firm Institutional Shareholder Services recommended Eidos merger with BridgeBio)
Endo International PLC ENDP
Fulgent Genetics Inc FLGT
I-Mab ADR IMAB
Jaguar Health Inc JAGX
Masimo Corporation MASI
Ocugen Inc OCGN (reacted to its Indian partner receiving conditional approval for coronavirus vaccine in the Indian market)
Organogenesis Holdings Inc ORGO
Otonomy Inc OTIC
PMV Pharmaceuticals Inc PMVP
PRA Health Sciences Inc PRAH
Precigen Inc PGEN
Silence Therapeutics ADR Representing 3 Ord Shs SLN
TRACON Pharmaceuticals Inc TCON
United Therapeutics Corporation UTHR
Vincera Pharma Inc VINC
Vistagen Therapeutics Inc VTGN
X T L Biopharmaceuticals Ltd XTLB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Jan. 4)

4D Molecular Therapeutics Inc FDMT
Aprea Therapeutics Inc APRE
Calithera Biosciences Inc CALA (reported adverse outcome for the Phase 2 study of telaglenastat in patients with advanced or metastatic renal cell carcinoma)
Intercept Pharmaceuticals Inc ICPT
Vivos Therapeutics Inc VVOS

Stocks In Focus

Moderna Gets Israeli Regulatory Nod For Coronavirus Vaccine Candidate

Moderna Inc MRNA announced that Israel's Ministry of Health has given authorization to import Moderna's mRNA-1273, its vaccine candidate against the novel coronavirus.

"This is the third regulatory authorization for the COVID-19 Vaccine Moderna, and its first outside of North America," said Stéphane Bancel, CEO of Moderna.

"We hope to continue to see authorizations in additional markets in the coming days, weeks and months."

Israel has secured 6 million doses of mRNA-1273 and first deliveries are expected to begin shortly, the company said.

The stock was up 1.14% to $113 in premarket trading.

Roche's Cancer Drug Combo Gets Breakthrough Therapy Designation For Lung Cancer

Roche Holdings AG Basel ADR Common Stock RHHBY said the FDA granted breakthrough therapy designation for tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, in combination with Tecentriq for the first-line treatment of people with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations

The stock edged up 0.22% to $44 in after-hours trading.

Gritstone Oncology Rallies On Insider, Fund Buying

Gritstone Oncology Inc GRTS shares rallied in reaction to a filing which revealed that biotech-focused hedge fund EcoR1 Capital, LLC built up a 9.9% stake in the company.

A separate filing showed Thomas Woiwode, a member of the company's board of directors, bought 1.35 million shares in the company at $3.71 each.

The stock was jumping 19.16% higher to $4.85 premarket Tuesday.

Tonix to Collaborate With Massachusetts General Hospital For Organ Transplant Rejection Treatment

Tonix Pharmaceuticals Holding Corp TNXP announced the signing of a second research collaboration agreement with Massachusetts General Hospital to develop TNX-1500, a humanized monoclonal antibody that targets the CD40-ligand for the prevention and treatment of organ transplant rejection.

In premarket trading Tuesday, Tonix shares were jumping 8.39% to 78 cents.

Marker Announces Lifting of Clinical Hold On Acute Myeloid Leukemia Study

Marker Therapeutics, Inc. MRKR said the FDA lifted the partial clinical hold on its Phase 2 trial investigating the safety and efficacy of MT-401, its lead, multi-tumor-associated, antigen-specific T cell product candidate for the treatment of post-transplant acute myeloid leukemia.

BioXcel Says BXCL501 Aces Phase 1b/2 Study In Treating Dementia-Related Agitation

BioXcel Therapeutics Inc BTAI said its BXCL501, an orally dissolving thin film formulation of dexmedetomidine, met the primary and secondary endpoints of the TRANQUILITY Phase 1b/2 trial that evaluated the pipeline asset at the 60 mcg dose level for treating agitation related to dementia, including Alzheimer's disease.

Topline results from the evaluated doses showed that BXCL501 was generally well-tolerated, with rapid and durable reductions observed in measures of acute agitation with the 60 mcg dose.

The stock was moving up 7.77% to $56.31 in premarket trading Tuesday.

Myovant's Recently Approved Prostate Cancer Treatment Now Available In US

Myovant Sciences Ltd MYOV announced the U.S. commercial availability of Orgovyx, the first and only oral gonadotropin-releasing hormone receptor antagonist approved by the FDA, for the treatment of adult patients with advanced prostate cancer.

In premarket trading Tuesday, Myovant shares were adding 3.06% to $25.59.

Checkmate Names Pharma Industry Veteran Robert Dolski As CFO

Checkmate Pharmaceuticals Inc CMPI announced the appointment of biopharma industry veteran Robert Dolski as its chief financial officer.

The company also said it recently strengthened its leadership team by naming Katherine Eade as General Counsel.

aTyr's Lead Candidate Aces Midstage Study In Hospitalized COVID-19 Patients

aTyr Pharma Inc LIFE announced positive topline results from its Phase 2 clinical trial of its lead therapeutic candidate, ATYR1923, in hospitalized COVID-19 patients with severe respiratory complications who do not require mechanical ventilation.

The trial met its primary endpoint of safety, demonstrating that a single, intravenous dose of ATYR1923 was generally safe and well-tolerated in both the 1.0 and 3.0 mg/kg treatment groups, with no drug-related serious adverse events, the company said.

"We are very encouraged by the signal of clinical activity seen in the 3.0 mg/kg cohort of ATYR1923. The relatively faster time to recovery seen by adding a single dose of ATYR1923 to standard of care treatment and the greater proportion of patients recovering within a week compared to placebo give us further confidence in this signal," said Sanjay Shukla, CEO of aTyr.

The stock was up 6.8% premarket at $4.24.

Zosano Requests FDA Meeting On Migraine Drug Application

Zosano Pharma Corp ZSAN said on Dec. 30 that the company requested a Type A meeting with the FDA.

The purpose of the Type A meeting is to receive FDA input on the requirements for the resubmission of the NDA for its migraine treatment candidate Qtrypta following the complete response letter received on Oct. 20.

The FDA typically responds to a sponsor's request for a Type A meeting, if granted, with a meeting scheduled within 30 days from the receipt of the request.

Zosano shares were trading 42.93% higher at 83 cents premarket Tuesday.

Cerecor Announces Positive Results Phase 2 Study Of CERC-002 In Hospitalized COVID-19 Patients

Cerecor Inc CERC announced positive results from its exploratory, Phase 2 U.S.-based proof of concept trial of the human anti-LIGHT monoclonal antibody CERC-002 in hospitalized patients with COVID-19 associated pneumonia and mild-to-moderate acute respiratory distress syndrome.

The trial demonstrated robust improvement in the primary endpoint — the proportion of patients alive and free of respiratory failure over the 28-day study period — compared to placebo.

The stock was jumping 24.62% to $3.29 in premarket trading Tuesday.

ImmunoGen Insiders Buy Shares

ImmunoGen, Inc. IMGN shares moved to the upside after a series of filings revealed purchase of the company's shares by company insiders.

In after-hours trading, the stock gained 5.93% to $6.88.

Puma Biotechnology Shares Drop On Insider Selling

Puma Biotechnology Inc PBYI shares came under pressure after a SEC filing on Form 4 revealed that its CEO Alan Auerbach sold 355 shares in the company at $11.656 per share. A separate filing showed that Richard Bryce, the company's chief medical and scientific officer sold 92 shares at a price of $11.65 per share.

The stock shed 5.52% to $9.76 in after-hours trading.

Offerings

Generation Bio Co GBIO said in a filing it plans to offer 7.5 million shares of its common stock in a follow-on offering.

In after-hours trading, the stock slipped 4.42% to $28.75.

Fate Therapeutics Inc FATE said it has commenced an underwritten public offering of $350 million in shares of common stock.

The company said it intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies of its product candidates, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, the conduct of preclinical R&D, and for general corporate purposes.

The stock was down 4.10% to $86 in after-hours trading.

Prelude Therapeutics Inc PRLD said it has commenced a public offering of 1.75 million shares of its common stock in a follow-on offering. All shares of common stock to be sold in the offering will be sold by the company.

NGM Biopharmaceuticals Inc NGM said it has commenced an underwritten public offering of $100 million in shares of its common stock. All of the shares in the proposed offering will be sold by the company.

In after-hours trading, the stock fell 2.63% to $28.48.

On The Radar

Clinical Readouts

Mersana Therapeutics Inc MRSN is scheduled to release updated data from the ovarian cancer cohort of the Phase 1 expansion study evaluating XMT-1536, its first-in-class ADC candidate targeting NaPi2b. The presentation is due at the company's virtual analyst and investor event.

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