The Daily Biotech Pulse: Sanofi-Translate Bio Join Hands For Coronavirus Vaccine, TherapeuticsMD Suspends Guidance

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

None of the NYSE- or Nasdaq-listed biotech stocks hit 52 week highs Thursday.

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on March 26)

• Aptevo Therapeutics Inc APVO (reacted to its fourth-quarter results)
• TFF Pharmaceuticals Inc TFFP

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Stocks In Focus

Sanofi's Multiple Myeloma Drug Gets Positive European Regulatory Agency Committee Opinion

Sanofi SA SNY said the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Sarclisa in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

In premarket trading Friday, the stock was up 1.28% to $43.50.

Translate Bio, Sanofi to Partner for COVID-19 Vaccine Research

Translate Bio Inc TBIO Bio said it will collaborate with Sanofi to develop a mRNA vaccine for COVID-19, joining a host of companies working on a vaccine for the SARS-CoV-2. Translate Bio has begun to produce multiple mRNA constructs, and it expects to use its mRNA platform for developing SARS-CoV-2 vaccine candidate.

Separately, Translate Bio said the FDA has granted Rare Pediatric Disease designation for MRT5005 for the treatment of cystic fibrosis, its first inhaled mRNA therapeutic. The company also said it expects interruptions in enrolment, dosing and follow-up in the ongoing Phase 1/2 trial in patients with cystic fibrosis.

It said it will provide an updated timing on the interim data readout of the additional single-ascending dose group and the multiple ascending dose portion of the trial at a later date.

Translate Bio shares were jumping 21.95% to $12.50 in premarket trading Friday.

TherapeuticsMD Suspends FY20 Guidance, Announces Cost Cuts

TherapeuticsMD Inc TXMD pre-announced first-quarter total net revenues of more than $11 million, while analysts expect revenues of $11.64 million. The company said it is suspending its 2020 guidance, citing the unknown impact of COVID-19 on its business.

The company also announced measures to cut or defer more than $30 million in annual spending.

The stock was slipping 7.75% to $1.19 in premarket trading Friday.

Zealand Announces Private Placement of Common Stock

Danish biotech ZEALAND PHARMA/S ADR ZEAL announced a private placement and directed share issue of 741,816 new ordinary shares to a U.S.-based investor at 185 Danish Krone per new ordinary share. The company said it expects to receive gross proceeds from the placement of about 137,236,000 Danish Krone.

The company said it will use the net proceeds for supporting its peptide platform, accelerating development of late stage assets, and prepare for the launch of its first fully-owned asset.

Arbutus Announces Positive Early-stage Results For Hepatitis B Drug

Arbutus Biopharma Corp ABUS announced positive preliminary results from a Phase 1a/1b clinical study of its RNAi therapy AB-729 in healthy subjects and two cohorts of chronic hepatitis B subjects on nucleos(t)ide antiviral therapy. The study was meant to determine the most effective dose and dosing interval for use in future Phase 2 combination clinical trials.

"These encouraging preliminary results demonstrate that AB-729 is a potent RNAi agent capable of reducing HBsAg plasma levels and support its further development as a treatment for people living with chronic hepatitis B," the company said.

The stock was advancing 3.98% to $2.35 in premarket trading Friday.

Earnings

Neubase Therapeutics Inc's NBSE fourth quarter net loss widened from 25 cents in 2018 to 26 cents in 2019, but was narrower than the consensus loss estimate of 32 cents per share. The company said its current cash balance will provide sufficient capital to fund operations through the end of fiscal year 2020.

In premarket trading Friday, Neubase shares were rallying 19.28% to $6.99.

NovaBay Pharmaceuticals, Inc.'s NBY fourth-quarter revenues fell from $3.6 million in 2018 to $1.7 million in 2019. The net loss per share widened from 7 cents to 13 cents. Analysts had estimated a loss of 7 cents per share.

The stock was plunging 10.92% to 78 cents in premarket trading Friday.

aTyr Pharma Inc LIFE reported total revenues of $0.1 million and a loss of $1.54 per share for the fourth quarter of 2019. In the year-ago quarter, the company reported no revenues and a loss of $2.92 per share. The consensus estimate had called for a loss of $1.59 per share for the recent fourth quarter.

As of Dec. 31, the company had cash, cash equivalents and investments of about $31.1 million.

In premarket trading, the shares were adding 5.84% to $3.26.

Vir Biotechnology Inc VIR, which is working on a cure for the new coronavirus, reported a decline in its fourth-quarter revenues from $3.1 million in 2018 to $1 million in 2019. The net loss per share widened from $3.05 to 71 cents, while analysts estimated a loss of 67 cents per share for the quarter.

The stock was advancing 5% to $33.60 in premarket trading.

On The Radar

Earnings

TELA Bio Inc TELA (before the market open)
Zyla Life Sciences ZCOR (before the market open)
Ocugen Inc OCGN (before the market open)
Altimmune Inc ALT (before the market open)