Week Ahead In Pharma: FDA Decision, Review Of COVID-19 Vaccine, Data Readouts (MRNA, BCRX, ARVN…)

The week that just passed by saw a couple of stocks belonging to the healthcare sector record triple-digit gains and nearly a dozen managing to log gains in excess of 50 percent, thanks to positive clinical trial readouts.

Greenwich LifeSciences Inc. (GLSI), which closed out the week at $56, delivering over 890%, was the top gainer of the week, following promising five year-data related to its drug candidate GP2 in a phase II clinical trial in HER2 positive women with operable breast cancer.

Curis Inc. (CRIS) closed the week at $7.89, recording a weekly gain of nearly 320%, on the back of positive preliminary data from its ongoing phase I study of CA-4948 monotherapy in patients with relapsed or refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes.

SELLAS Life Sciences Group Inc. (SLS) closed out the week at $8.37, making a gain of over 116%, following a license agreement with China-based 3D Medicines and in the run-up to the positive follow-up data from its phase II trial of Nelipepimut-S in women with ductal carcinoma in-situ of the breast.

Xenetic Biosciences Inc. (XBIO) finished the week at $2.28, delivering over 100% gain, on news of its partner PJSC Pharmsynthez reporting encouraging data from its pivotal phase III clinical study of Epolong as a treatment for anemia in patients with chronic kidney disease. PJSC Pharmsynthez developed its investigational drug Epolong leveraging Xenetic’s patent-protected platform technology PolyXen.

Now, let’s take a look at some of biotech/pharma stocks that merit attention during the week of December 14.

1. Cellectar Biosciences Inc. (CLRB)

Cellectar Biosciences is scheduled to present data from its phase I study of CLR 131 in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma, osteosarcoma and lymphomas (including Hodgkin’s lymphoma) at the upcoming International Symposium on Pediatric Neuro-Oncology (ISPNO) annual meeting taking place December 13-16 in Karuizawa, Japan.

CLRB closed Friday’s trading at $2.19, up 4.78%.

2. BioCryst Pharmaceuticals Inc. (BCRX)

BioCryst will be making a presentation at the JMP Securities Hematology Summit on December 15. Early this month, the company received FDA approval for its oral, once-daily ORLADEYO for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. This drug is also under review in Japan and Europe, with a decision expected this month and March, respectively. A phase I clinical trial of BCX9250, inhibitor discovered and developed by BioCryst for the treatment of fibrodysplasia ossificans progressive, is underway, with data due this month.

The company is also evaluating its investigational broad-spectrum antiviral drug Galidesivir in hospitalized adults diagnosed with moderate to severe COVID-19. Data from part I of this trial is expected to be reported this month. The primary endpoint of part 1 is safety.

BCRX closed Friday’s trading at $8.12, up 6.14%.

3. Arvinas Inc. (ARVN)

Arvinas will be providing clinical program updates for its investigational drugs ARV-471 and ARV-110 on December 14.

ARV-471 is under phase I dose escalation study in patients with locally advanced or metastatic ER positive/HER2 negative breast cancer and ARV-110 is under phase I dose escalation study in men with metastatic castrate-resistant prostate cancer.

ARVN closed Friday’s trading at $29.93, up 0.57%.

4. TCR2 Therapeutics Inc. (TCRR)

TCR2 Therapeutics is expected to report interim update from the phase I portion of its phase I/II clinical trial of TC-210 for patients with mesothelin-expressing solid tumors on Monday, December 14.

TC-210, a T-cell therapy, targets four indications – non-small cell lung cancer, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma. The initial data reported from the phase I portion of the trial, in July of this year, demonstrated that at the first suboptimal dose of TC-210, there was a 100% disease control rate as well as a 40% overall response rate.

TCRR closed Friday’s trading at $32.63, up 2.51%.

5. Gossamer Bio Inc. (GOSS)

Gossamer is all set to present initial results from the ongoing two-week phase Ib clinical trial of inhaled GB002 in Pulmonary Arterial Hypertension on December 15. The trial is designed to enroll 16 participants and eligible subjects who have completed the 2 week treatment period have the option to participate in a 24 week open label extension.

GOSS closed Friday’s trading at $10.10, up 4.55%.

6. Moderna Inc. (MRNA)

The FDA’s Advisory Committee will meet on December 17 to discuss Emergency Use Authorization of Moderna Inc.’s (MRNA) COVID-19 vaccine candidate mRNA-1273 for the prevention of COVID-19 in individuals 18 years and older. In a phase III study, mRNA-1273 demonstrated a vaccine efficacy of 94.1%. The U.S government has ordered 200 million doses of mRNA-1273 vaccine to date and has the option to purchase up to an additional 300 million doses.

MRNA closed Friday’s trading at $156.93, up 0.80%.

7. MacroGenics Inc. (MGNX)

The FDA decision on MacroGenics’ lead drug candidate Margetuximab is expected on December 18. Margetuximab in combination with chemotherapy is proposed as a treatment for patients with metastatic HER2-positive breast cancer.

The company has a deal in place with EVERSANA, a pioneer of next-generation commercial services to the global life sciences industry, which was inked as recently as last month, to commercialize Margetuximab in the United States, if approved.
MacroGenics and Zai Lab have an exclusive collaboration and license agreement for the development and commercialization of Margetuximab in Greater China (mainland China, Hong Kong, Macau and Taiwan) that was signed in 2018.

MGNX closed Friday’s trading at $22.19, down 2.20%.

8. Amgen Inc. (AMGN)

Amgen’s ABP 798, the biosimilar version of Roche’s Rituxan, is under FDA review, with a decision anticipated on December 19. There are already two approved biosimilars to Rituxan – Teva/ Celltrion Healthcare’s Truxima, which was approved in November 2018, and Pfizer’s Ruxience, which was approved in July 2019. Amgen is collaborating with Allergan for the development of ABP 798.

Rituxan is approved for the treatment of adult patients alone or in combination with chemotherapy for non-Hodgkin’s lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids, among others. Rituxan generated global annual sales of $6.7 billion for Roche in 2019.

AMGN closed Friday’s trading at $227.40, down 0.33%.

9. Myovant Sciences Ltd. (MYOV)

The FDA decision on Myovant’s Relugolix, proposed for the treatment of men with advanced prostate cancer, is slated for December 20. Relugolix, if approved, will compete with AbbVie’s Lupron and AstraZeneca’s Zoladex.

Relugolix is also under review for the treatment of women with heavy menstrual bleeding associated with uterine fibroids, with a decision anticipated on June 1, 2021. Analysts expect Relugolix to achieve sales of $200 million by 2025.

MYOV closed Friday’s trading at $25.28, down 3.81%.

10. vTv Therapeutics Inc. (VTVT)

Shares of vTv Therapeutics are picking up steam as the company gears up to report topline results from its phase II study of Azeliragon in patients with mild Alzheimer’s disease and type 2 diabetes this month. The study, dubbed Elevage, has enrolled 43 patients, and is designed to evaluate the effect of six-months of treatment with Azeliragon on cognitive performance.

VTVT closed Friday’s trading at $3.10, up 41.55%.

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