The Daily Biotech Pulse: Kura's Blood Cancer Drug Study Gets Partial Clinical Hold, Takeda FDA Nod, Puma Breast Cancer Treatment Gets Patent Extension

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

Stocks In Focus

Puma Biotech Announces Receipt Of Patent Extension For Breast Cancer Drug By 5 Years

Puma Biotechnology, Inc. PBYI announced the U.S. Patent and Trademark Office issued a patent term extension certificate, extending the patent regarding the composition of matter claims for its breast cancer drug Nerlynx by five years.

The patent will now expire on Dec. 29, 2030.

The stock was up 5.66% to $3.36 in premarket trading.

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Takeda Receives FDA Approval For Drug to Treat Post-Transplant Cytomegalovirus Infection

Takeda Pharmaceutical Company Limited TAK announced the U.S. Food and Drug Administration has approved Livtencity for the treatment of adults and pediatric patients with post-transplant cytomegalovirus infection/disease that is refractory to treatment with ganciclovir, valganciclovir, cidofovir, or foscarnet.

Livtencity is Takeda's second new molecular entity to receive FDA approval in fiscal year 2021.

In premarket trading, the stock was gaining 0.87% to $13.91.

BeiGene's Brukinsa Receives European Regulatory Nod For A Type of Rare Blood Cancer

BeiGene, Ltd. BGNE announced the European Commission approved Brukinsa for the treatment of adult patients with Waldenström's macroglobulinemia, who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy. The approval is applicable to all 27 European Union member states, plus Iceland and Norway.

Brukinsa received FDA approval for the same indication in early September.

Kura's Phase 1b Study Of Blood Cancer Drug Placed On Partial Clinical Hold Following A Patient Death

Kura Oncology, Inc. KURA announced that the FDA has placed the KOMET-001 Phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukemia on a partial clinical hold. The partial clinical hold was initiated following the company's recent report to the FDA of a Grade 5 serious adverse event potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML.

Patients currently enrolled in the Phase 1b study may continue to receive KO-539, although no additional patients may be enrolled until the partial clinical hold is resolved. Kura said it is working closely with the FDA and the site investigators to resolve the partial clinical hold as quickly as possible.

The stock was slumping 40.36% to $9.90 in premarket trading.

AgeX Receives NYSE Letter Regarding Deficiency With Respect To Certain Listing Standards

AgeX Therapeutics, Inc. AGE said on Nov. 17, it received a letter from the staff of the NYSE American, indicating that AgeX does not meet certain of the exchange's continued listing standards

AgeX is now required to provide the exchange staff with a plan by Dec. 17, explaining the action it has taken and will take that would bring AgeX into compliance with the continued listing standards by June 17, 2023.

The stock was down 3.82% at 73.10 in premarket trading.

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


Outlook Therapeutics, Inc. OTLK said, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 40 million shares of common stock at a price to the public of $1.25 per share.

The stock was slipping 20.51% to $1.24 in premarket trading.

On The Radar


Centogene N.V. CNTG (before the market open)
Anavex Life Sciences Corp. AVXL (after the close)

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