Week Ahead In Pharma: FDA Decisions, Data Readouts (ADMP, EIGR, KZIA, AVRO…)

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The week ending November 13 finished on a positive note - raising hopes of an effective COVID-19 vaccine, with Pfizer and BioNTech announcing on Nov.9, that their vaccine candidate BNT162b2 has been found to be more than 90% effective in preventing the infection.

Five Prime Therapeutics Inc. (FPRX), which returned over 328%, was the top gainer of the week. The company reported positive topline results from a phase II trial of its drug candidate Bemarituzumab in patients with advanced gastric or gastroesophageal junction (GEJ) cancer on November 11.

Let's take a look at some of the stocks that merit attention in the week ahead.

FDA Decisions

1. Adamis Pharmaceuticals Corp. (ADMP)

Adamis Pharma's ZIMHI Injection, proposed for the reversal of opioid overdose, awaits the FDA decision, due on November 15. ZIMHI is a 5 mg dose of Naloxone.

Naloxone has been used as the standard treatment for opioid overdose for more than 45 years, and the currently approved dose is only 2 mg. Last November, the FDA had denied approval to ZIMHI, citing issues related to Chemistry, Manufacturing and Controls (CMS).

The addressable market opportunity for ZIMHI is estimated to be $330 million, according to IQVIA National Sales Perspective.

ADMP has traded in a range of $0.27 to $1.51 in the last 1 year. The stock closed Friday's trading at $0.68, down 4.59%.

2. Alkermes plc (ALKS)

Alkermes' ALKS 3831, proposed for the treatment of bipolar I disorder, awaits the decision of the U.S. regulatory agency, due on November 15.

Last month, an FDA panel had voted to recommend approval of ALKS 3831. The FDA usually follows the recommendations of its panels although it is not required to do so.

If approved, analysts expect ALKS 3831 to achieve *$364 million in peak sales in 2026. (Source: GlobalData).

ALKS has traded in a range of $11.98 to $21.88 in the last 1 year. The stock closed Friday's trading at $17.80, up 2.77%.

3. Bristol-Myers Squibb Co. (BMY)

The FDA decision on Bristol Myers' Lisocabtagene maraleucel, proposed for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies, is slated for November 16.

If approved, Lisocabtagene maraleucel, or Liso-cel in short, would compete with the two FDA-approved CAR T-cell therapies for large B-cell lymphoma namely Novartis' Kymriah and Gilead Sciences' Yescarta.

According to a report compiled by GlobalData, Liso-cel is expected to achieve peak sales of $1.3 billion in 2026.

BMY has traded in a range of $45.76 to $68.34 in the last 1 year. The stock closed Friday's trading at $63.62, up 1.39%.

4. Eiger BioPharmaceuticals Inc. (EIGR)

Eiger BioPharma's Zokinvy, proposed for the treatment of Progeria and Progeroid Laminopathies, awaits the FDA decision on November 20.

Progeria, also known as Hutchinson-Gilford Progeria Syndrome (HGPS), is an ultra-rare and fatal genetic condition of accelerated aging in children. It is estimated that 400 children across the globe have Progeria and an equal number of children have Progeroid Laminopathies.

Currently, there are no treatments for Progeria.

EIGR has traded in a range of $4.55 to $15.82 in the last 1 year. The stock closed Friday's trading at $10.55, up 2.83%.

Data Readouts

1. Kazia Therapeutics Limited (KZIA) is slated to present further data from its lead drug candidate Paxalisib in glioblastoma at the Society for Neuro-Oncology (SNO) Annual Meeting to be held November 19 -21. Interim data reported from the phase II study, reported in June, showed that Paxalisib was associated with an overall survival of 17.7 months and a progression-free survival of 8.5 months. The existing, FDA-approved standard of care, Temozolomide, is associated with an overall survival of 12.7 months and a progression-free survival of 5.3 months.

2. Lineage Cell Therapeutics Inc. (LCTX) will be presenting updated interim results from its ongoing phase I/IIa study of its lead product candidate OpRegen in patients with dry age-related macular degeneration with geographic atrophy at the 2020 American Academy of Ophthalmology Annual Meeting on November 15.

3. AVROBIO Inc. (AVRO) is scheduled to present new and updated data from three of its investigational gene therapies on November 17. The data that will be provided that day include the initial data on the first patient dosed in the phase I/II trial of AVR-RD-02 for Gaucher disease, new data on the first two patients dosed in the investigator-sponsored phase I/II study of AVR-RD-04 for cystinosis, as well as updated patient data from the phase I and phase II clinical trials of AVR-RD-01 for Fabry disease.

4. RAPT Therapeutics Inc. (RAPT) will be presenting initial data from its phase I/II clinical trial of FLX475 in patients with multiple cancer indications on November 16. The phase I healthy volunteer study and phase I portion of the trial in cancer patients have been successfully completed, with FLX475 showing no safety issues and demonstrating encouraging evidence of clinical activity. The phase II portion of the phase I/II study of FLX475 as a monotherapy, and in combination with Keytruda in patients with "charged" tumors is underway.

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