The Daily Biotech Pulse: Genmark Pre-Announces Q1 Outperformance, Sage to Eliminate 53% of Workforce, Keros IPO

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 7)

• Dr.Reddy's Laboratories Ltd RDY
• Masimo Corporation MASI
• Seattle Genetics, Inc. SGEN
• Vertex Pharmaceuticals Incorporated VRTX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 7)

• Celcuity Inc CELC
• Curis, Inc. CRIS
• Helius Medical Technologies Inc HSDT
• Menlo Therapeutics Inc MNLO
• TherapeuticsMD Inc TXMD
• Zentalis Pharmaceuticals Inc ZNTL

Stocks In Focus

COVID-19 Test Sales to Lift GenMark's Q1 Results; Company Raises 2020 Guidance

GenMark Diagnostics, Inc GNMK announced preliminary first-quarter results, expecting revenues of about $38.7 million, a 80% year-over-year increase. The company noted that about 80% gross placements included interest in COVID-19 testing SARS-CoV-2 consumable revenues. Analysts, on average, estimate revenues of $24.8 million.

The company also raised its full-year revenue guidance from $100-$110 million to $112-$122 million, while the consensus calls for revenues of $108.58 million.

The stock climbed 29.56% to $5.83 in after-hours trading.

Zomedica Prices Offering of Common Stock, Warrants

Zomedica Pharmaceuticals Corp ZOM said it has priced its previously announced public offering of 33.33 million shares and warrants to purchase up to 1.667 million shares. The company expects gross proceeds of about $4 million from the offering. The offering is expected to close on or about April 9.

In after-hours trading, the shares shed 9.95% to 15 cents.

Mersana Raises $65M Through At-The-Market Facility

Mersana Therapeutics Inc MRSN said it has raised gross proceeds of about $65 million through at-the-market facility with participation based on interest received from Avoro Capital Advisors LLC, Bain Capital Life Sciences, Consonance Capital Investors and David Mott, Mersana's Chairman.

The company said it sold about 8.9 million shares at $5.50 per share and 2 million shares at the closing price of $7.74 per share, in each case the market price at the time of sale.

Bristol-Myers Squibb Announces Acceptance of U.S. and European Regulatory Submissions for Combo Immunotherapy For Lung Cancer

Bristol-Myers Squibb Co BMY said the U.S. FDA accepted its sBLA for Opdivo-Yervoy combo with a limited course of chemotherapy for the first-line treatment of patients metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. The European Medicines Agency has also validated a type II variation application for the same combo for the same indication, it added.

Acceleron's Hypertension Drug Gets Breakthrough Therapy Designation

Acceleron Pharma Inc XLRN said the FDA has granted Breakthrough Therapy Designation to sotatercept for the treatment of patients with pulmonary arterial hypertension.

FDA Extends Review Period For Roche's Spinal Muscular Atrophy Drug By 3 Months

Roche Holdings AG Basel RHHBY said the FDA has extended the PDUFA date for the review of its NDA for risdiplam by three months to Aug. 24 due to a recent submission of additional data made by Roche, including data from the pivotal SUNFISH Part 2 study.

Sage Announces Restructuring, Including Workforce Reduction, to Conserve Cash

SAGE Therapeutics Inc SAGE announced a restructuring initiative that would help it to advance its corporate strategy and pipeline. The initiative includes elimination of about 53% of its workforce and a reduction in external expenses, which together is expected to result in annualized savings of about $170 million, of which $150 million is related to SG&A expenses.

The company said the workforce reduction will primarily affect Zulresso CIV injection commercial operation and related SG&A support functions.

Based on the current operating plan and assumptions, Sage expects its cash position to support operations into 2022.

The stock added 1.07% to $29.34 in after-hours trading.

Idera Announces Private Placement of Up to $20.7M Worth Common Stock and Warrants

Idera Pharmaceuticals Inc IDRA announced an funding agreement for privately placing shares of its common stock together with accompanying warrants to purchase additional shares of common stock in two tranches, with the second tranche to be made at the option of the investor.

Depending on the extent to which Tranche 2 is closed, and inclusive of proceeds from the exercise of warrants issuable in this private placement, the company said it will receive up to $20.7 million in gross proceeds.

The company said it plans to use the proceeds primarily to fund completion of its ongoing ILLUMINATE-301 trial of its lead product tilsotolimod for the treatment of anti-PD-1 refractory metastatic melanoma.

The stock surged up 29.03% to $1.60 in after-hours trading.

Organovo Terminates Merger With Tarveda

Organovo Holdings Inc ONVO, a developer of 3-D bioprinted tissues comprising human cells, said it has terminated the merger agreement with Tarveda Therapeutics, which was originally announced Dec. 16. The decision follows Organova's shareholders rejecting the merger at a special meeting of stockholders.

The shareholders, meanwhile, approved the proposal to effect a reverse stock split of one share for every 20 to 40 shares of existing common stock.

The stock slipped 3.30% to 28 cents in after-hours trading.

MediciNova to Initiate Clinical Trial of Investigational Asset MN-166 For COVID-19-induced Respiratory Distress

MediciNova, Inc. MNOV said it will initiate a clinical trial of MN-166 for acute respiratory distress syndrome caused by COVID-19.

"We are very pleased to announce initiation of a clinical trial of MN-166 in ARDS caused by COVID-19. This study also will allow investigators to determine the optimal dose and route of administration in these very critical patients," said Yuichi Iwaki, CEO of MediciNova.

Announcements On COVID-Related Impacts

Myriad Genetics, Inc. MYGN announced withdrawal of its 2020 financial guidance, citing the impact of the COVID-19 pandemic.

"….recent social distancing guidelines have had a significant impact on test volume trends in late March and into the fiscal fourth-quarter," said Bryan Riggsbee, interim president and CEO and chief financial officer at Myriad Genetics.

Trillium Therapeutics Inc TRIL said it expects a slowdown or potentially a pause in new patient enrolment in its TTI-621 and TTI-622 dose escalation studies. The company, however, said its strong financial position, with about $135 million in cash and investments, will enable it to tide through the crisis and also execute on its key strategic objectives.

On The Radar

IPO

Keros Therapeutics, which develops therapies for hematological and neuromuscular disorders, said it has priced its upsized initial public offering, or IPO, of 6 million at $16 compared to the estimated range of $14-$16. The company's shares will begin trading on the Nasdaq under the ticker symbol KROS.