CRON Goes Up In Smoke On Citron Report, Hot AFMD Is Cooling Now, REPL On Watch

pharma losers 083018

The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. Cronos Group Inc. (CRON)

Lost 28.41% to close Thursday's (Aug.30) trading at $9.12.

News: Short seller Citron Research in a report titled "Cronos:The Dark Side of The Cannabis Space", alleges that "Cronos management appears to have been deceiving the investing public by purposely not disclosing the size of its distribution agreements with provinces - unlike every other major cannabis player".

On August 21, the Company announced its initial supply agreements for retail distribution, both government-operated and private, across Canada for the upcoming launch of the cannabis recreational market in October 2018.

The stock has been on fire lately, touching a new intraday high of $12.89 on August 27, which represented a gain of over 107% for the month.

2. Eagle Pharmaceuticals Inc. (EGRX)

Lost 16.28% to close Thursday's trading at $68.34.

News: The Company has completed enrollment in its second clinical study to further evaluate the safety and efficacy of RYANODEX for the treatment of exertional heat stroke, an investigational new indication for the product.

The randomized and double-blinded study was conducted at four Emergency Departments in the Makkah region of Saudi Arabia during the 2018 Hajj Season, which took place August 19-24, 2018. The study enrolled seven severely ill exertional heat stroke (EHS) patients. Based on a preliminary analysis of the data, EHS patients who received RYANODEX plus Standard of Care ("SOC"), which consists of body cooling by physical methods and supportive measures, showed an additive benefit compared to patients receiving cooling only.

The initial safety and efficacy study of RYANODEX for EHS, conducted in September 2015, had also demonstrated that administration of RYANODEX in addition to the standard of care had substantial efficacy in treating patients with EHS, compared to SOC alone.

The Company plans to meet with the FDA to discuss the next steps. RYANODEX is already approved for the treatment of malignant hyperthermia.

3. Affimed N.V. (AFMD)

Lost 13.82% to close Thursday's trading at $5.30. The stock is giving back some of what it gained after signing a collaboration agreement with Genentech, a member of the Roche Group, on August 28.

News: No news

Recent event:

On August 28, the Company entered into a collaboration agreement with Genentech, a member of the Roche Group, to develop and commercialize novel NK cell engager-based immunotherapeutics to treat multiple cancers.

As per the agreement terms, Affimed is entitled to receive $96 million upfront and committed funding, and is eligible for up to an additional $5.0 billion over time, including milestone payments, and royalties on sales.

The news sent the stock up more than 246% to $5.55 that day (Aug.28), and it added another 32%, the following day to touch a new intraday high of $7.35 on Aug.29.

4. Replimune Group Inc. (REPL)

Lost 9.20% to close Thursday's trading at $18.65.

News: The Company announced financial results for its first fiscal quarter ended June 30, 2018, and provided an update on its business.

The net loss was $10.0 million for the quarter ended June 30, 2018 compared with $3.6 million for same period in the prior year. Replimune ended the quarter with $52.0 million in cash, which is expected to be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2021.

Clinical Trials & Near-term Catalysts:

The lead product candidate is RP1.

-- In the second half of calendar 2018, define the dose of RP1 intended for future use and initiate dosing of RP1 combined with Bristol-Myers' Opdivo in a cohort of 12 advanced cancer patients with a range of solid tumors, in the second part of the Phase 1 stage of the ongoing Phase 1/2 study.
-- In the first half of 2019, initiate dosing of approximately 120 patients with RP1 in combination with Opdivo, in four defined indications: metastatic melanoma, metastatic bladder cancer, microsatelite instability high cancer, and non-melanoma skin cancers.
-- In the first half of 2019, initiate a randomized, controlled Phase 2 clinical trial of RP1 in combination with cemiplimab, compared to cemiplimab alone, in approximately 240 patients with cutaneous squamous cell carcinoma.

Next up in the pipeline is RP2 for mixed advanced solid tumors, including triple negative breast cancer.

-- In the first half of 2019, file an IND with the FDA and/or a CTA with the MHRA in the United Kingdom for RP2.
-- In the second half of calendar 2018, finalize the RP3 product candidate to be progressed into clinical trials.

5. Scholar Rock Holding Corporation (SRRK)

Lost 9.69% to close Thursday's trading at $17.15.

News: Pfizer Inc.'s (PFE) decision to terminate two ongoing phase II clinical studies evaluating Domagrozumab for the treatment of Duchenne muscular dystrophy negatively impacted Scholar Rock.

Scholar Rock is developing a drug by the name SRK-015 in patients with later-onset SMA (Type 2 and Type 3).SRK-015 uniquely targets the latent form of myostatin, specifically blocking its activation in muscle.

Pfizer's Domagrozumab is also designed to work by blocking the activity of myostatin, and it did not meet its primary efficacy endpoint in the phase II studies, which led to termination of the studies.

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