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Week Ahead (February 15-19): Data Readouts, FDA Approval (KOD, EXEL, SESN, GTHX…)

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In the trading week ended Feb.12, more than 5 pharma stocks returned as much as over 80%.

KalVista Pharmaceuticals Inc. (KALV), which gained nearly 180%, was the top performer of the week, thanks to positive results from its phase II trial of KVD900 as an oral on-demand treatment for hereditary angioedema (HAE) attacks. The stock closed the week at $42.57.

Artelo Biosciences Inc. (ARTL), a clinical stage biopharmaceutical company developing therapeutics that modulate endogenous signaling pathways, including the endocannabinoid system, was another triple-digit gainer of the week. ARTL closed the week at $2.66.

Now, let's take a look at some of the pharma stocks that merit attention in the coming week.

1. Dynavax Technologies Corporation (DVAX)

Dynavax is a commercial-stage biopharmaceutical company developing vaccines. The company's first commercial product, HEPLISAV-B, is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. This vaccine contains the adjuvant CpG 1018.

On Dec.10, 2020, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Heplisav B in the European Union, and a final decision on approval is expected this quarter.

Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships.

The company is scheduled to report fourth quarter and full year 2020 financial results on Thursday, February 25, 2021, after the U.S. financial markets close.

DVAX closed Friday's (Feb.12, 2021) trading at $9.74, up 2.20%.

2. Exelixis Inc. (EXEL)

Exelixis' phase II study comparing its CABOMETYX with Pfizers' Sutent in patients with metastatic papillary renal cell carcinoma, dubbed PAPMET, has demonstrated that there is a clinically and statistically significant benefit with CABOMETYX, according to the company.

The median progression-free survival, i.e., the trial's primary endpoint, was 9.0 months with CABOMETYX compared to 5.6 months with Sutent, which was statistically significant. The objective response rate was 23% for CABOMETYX versus 4% for Sutent.
The median overall survival was 20.0 months for CABOMETYX while it was 16.4 months for Sutent, which did not reach statistical significance.

PAPMET was supported by the National Cancer Institute (NCI), part of the National Institutes of Health, designed and led by the SWOG Cancer Research Network, and conducted through the NCI National Clinical Trials Network.

CABOMETYX in combination with Opdivo was approved by the FDA last month as a first-line treatment for patients with advanced renal cell carcinoma.

EXEL closed Friday's trading at $21.91, down 0.72%.

3. G1 Therapeutics Inc. (GTHX)

The FDA has approved G1 Therapeutics' COSELA to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

The approval news was reported by the company after the bell on Friday (Feb.12).

COSELA, known generically as Trilaciclib, and administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy, is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy.

G1 Therapeutics has a three-year co-promotion agreement with Boehringer Ingelheim for COSELA in small cell lung cancer in the U.S. and Puerto Rico that was inked in June 2020.

COSELA is slated to be commercially available through G1's specialty distributor partner network in early March. The peak sales of COSELA are pegged at $500 million by analysts.

GTHX closed Friday's trading at $30.89, down 5.22%.

4. Kodiak Sciences Inc. (KOD)

Kodiak Sciences presented one-year data from its ongoing phase Ib study of KSI-301 in wet age-related macular degeneration, Diabetic Macular Edema and Retinal Vein Occlusion cohorts at the Angiogenesis, Exudation and Degeneration 2021 Annual Meeting on Feb.13.

The data reveals that two-thirds of patients in each disease cohort achieved a 6-month or longer treatment-free interval at the one-year mark - i.e., 66% of wet AMD patients, 69% of DME patients and 66% of RVO patients. Moreover, 78% of wet AMD patients and 84% of DME patients were on a 4-month or longer treatment-free interval at Year 1, as were 75% of RVO patients.

KSI-301 is also being evaluated in a phase III study in wet AMD, dubbed DAZZLE, in a phase III study in DME known as GLEAM and in a phase III trial in RVO, dubbed BEACON. The DAZZLE wet AMD study is fully recruited while the GLEAM and GLIMMER trials actively recruiting. The topline data from the phase III trials are expected in 2022.

KOD closed Friday's trading at $157.03, down 2.20%.

5. Ocular Therapeutix Inc. (OCUL)

Ocular Therapeutix presented data from its Phase 1 clinical trial of OTX-TKI for the treatment of Neovascular AMD at the Angiogenesis, Exudations, and Degeneration 2021 Meeting on Feb.13.

OTX-TKI is an intravitreal implant of Axitinib delivered via injection, for the treatment of patients with wet AMD and other retinal diseases.

According to data presented last November, OTX-TKI was generally well tolerated and showed preliminary biological signal of clinically-meaningful decrease in retinal fluid. The study also demonstrated durability of therapy for up to 6 months and one subject demonstrated durability to 11 months.

OCUL closed Friday's trading at $19.38, down 1.92%.

6. Sesen Bio Inc. (SESN)

Sesen Bio is all set to host a conference call on Tuesday, February 16, 2021 at 8:00 a.m. ET to provide a business update.

The company's lead product candidate is Vicineum, being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

On Dec.18, 2020, the company submitted its completed Biologics License Application to the FDA for Vicineum.

Sesen Bio expects to learn if the BLA is accepted for filing by the FDA on February 16. If the BLA is accepted, the company expects to receive a decision on the following three items:

-- Priority vs. Standard review
-- Target PDUFA date for approval
-- Necessity of an FDA Advisory Committee meeting

SESN closed Friday's trading at $2.80, down 1.06%.

7. Soligenix Inc. (SNGX)

Soligenix is slated to deliver a corporate presentation at the BIO CEO & Investor Digital Conference on Feb.15.

Soligenix is a late-stage biopharmaceutical company developing products to treat rare diseases where there is an unmet medical need. The lead compound is SGX301, being investigated as a potential treatment for Cutaneous T-cell lymphoma. SGX301 has been successfully studies in a phase III trial and the company is preparing its new drug application for submission to the FDA.

Last December, the company announced that its phase III trial of SGX942 in the treatment of severe oral mucositis (SOM) in patients with head and neck cancer (HNC) receiving chemoradiation failed to meet its primary endpoint of median duration of SOM.

SNGX closed Friday's trading at $2.14, up 2.88%.

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