The Daily Biotech Pulse: Gilead's Blood Cancer Studies Placed On Partial Clinical Hold, Immunocore Gets FDA Nod, NRx Touts Positive COVID-19 Data

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

Stocks In Focus

Gilead Hit With FDA Partial Clinical Hold On Multiple Blood Cancer Studies Evaluating Magrolimab-Vidaza Combo

Gilead Sciences, Inc. GILD said the U.S. Food and Drug Administration has placed a partial clinical hold on studies evaluating the combination of magrolimab plus Bristol-Myers Squibb Co's BMY Vidaza due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms.

While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and Vidaza combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.

The stock was down 1.44% at $67.85 in premarket trading.

Click here to access Benzinga's FDA Calendar

MediciNova Receives Notice Of Intent to Grant European Patent Related to MN-001 & MN-002 In Hepatic Ballooning

MediciNova, Inc., MNOV announced that it has received a notice of intention to grant from the European Patent Office for a pending patent application that covers MN-001 and MN-002, a major metabolite of MN-001, for hepatic ballooning.

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than January 2035. The allowed claims cover the use of MN-001 or MN-002 for inhibiting hepatic ballooning,

The stock was up 6.55% to $2.44 in premarket trading.

Immunocore Announces FDA Approval For Treatment For Melanoma Of Eyes

Immunocore Holdings plc IMCR announced FDA approval of Kimmtrak, for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Tyme Announces Discontinuation Of Phase 2/3 Pancreatic Cancer Study Following Futility Analysis Vis-à-vis Chemotherapy

TYME Technologies, Inc. TYME announced the discontinuation of SM-88 with MPS in the Phase 2/3 "Precision Promise" trial in metastatic pancreatic cancer upon learning from the trial sponsor, Pancreatic Cancer Action Network that it terminated the arm due to futility compared to the control of standard of care chemotherapy in second-line mPDAC.

Based on the information provided by PanCAN, the overall survival for SM-88 with MPS in monotherapy was lower compared to standard of care chemotherapies with either Gemcitabine and Abraxane or modified Folfirinox.

The stock was down 10.38% at 47.51 cents in premarket trading.

NRx Reports Positive Safety & Survival Report From ‘Right To Use' Of Investigational COVID Treatment

NRx Pharmaceuticals NRXP announced the receipt of first safety report from a Southwestern hospital where physicians have administered Zyesami to patients with COVID-19 respiratory failure, showing of the first 19 patients treated by Dec. 31, three had died and 16 were reported to be alive by Jan. 22.

At the time of the report, 14 of these 16 patients had been discharged to a rehabilitation center or home and two remained in the hospital. No serious adverse events related to Zyesami were reported.

These patients were treated under the Federal "Right toTry" Law that gives access to investigational medicines for patients who have been diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options, and who are unable to participate in a clinical trial to access certain unapproved treatments.
The stock was up 7.26% to $3.40 in premarket trading.

ZIOPHARM Rebrands As Alaunos to Reflect Transition To TCR-T Cancer Therapies

ZIOPHARM Oncology, Inc. ZIOP announced recent operational and corporate updates and a change of its name to Alaunos Therapeutics, Inc. The change of name reflects the completion of the transition to a TCR-T focused company and embodies the mission of developing novel therapies for cancer patients, the company added.

The stock was rising 1.90% to 89 cents in premarket trading.

Offerings

Sierra Oncology, Inc. SRRA, which reported a positive late-stage readout for its myelofibrosis treatment, said it intends to offer and sell $100 million of shares of its common stock in an underwritten public offering.

The stock was down 6.08% at $21.30 in premarket trading.

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

On The Radar

Clinical Readouts/Presentations

Cue Biopharma, Inc. CUE will provide on Wednesday an update from the its ongoing clinical trials with CUE-101, its lead and representative IL-2 based drug product candidate from the CUE-100 series. CUE-101 is currently in a Phase 1b clinical trial for the treatment of HPV+ recurrent/metastatic head and neck squamous cell carcinoma.

Earnings

Abbott Laboratories ABT (before the market open)
Vertex Pharmaceuticals Incorporated VRTX (after the close)
Edwards Lifesciences Corporation EW (after the close)