AFMD Notches Triple-digit Gains, AXSM Strides Ahead, GERON Abuzz

(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.

1. Affimed N.V. (AFMD)

Gained 246.88% to close Tuesday's (Aug.28) trading at $5.55.

News: The Company has 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.

2. CEL-SCI Corp. (CVM)

Gained 26.26% to close Tuesday's trading at $2.26.

News: No news

Near-term Catalyst:

The top line results from a phase III trial of its investigational immunotherapy Multikine in the treatment of head and neck cancer may be available as soon as early 2019.

3. Axsome Therapeutics Inc. (AXSM)

Gained 18.81% to close Tuesday's trading at $3.00.

News: The Company announced that it will present a corporate overview at the 20th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC., on September 5, 2018.

Near-term Catalysts:

-- Results from final interim analysis of phase III trial of AXS-05 in treatment resistant depression, or TRD, known by the name STRIDE-1, are expected in the fourth quarter of 2018. -- Results of the first interim analysis of Phase 2/3 trial of AXS-05 in patients with agitation associated with Alzheimer's disease, dubbed ADVANCE-1, are expected in the fourth quarter of 2018. -- Top line results from a phase II trial of AXS-05 in patients with major depressive disorder, dubbed ASCEND, are anticipated in the fourth quarter of 2018. -- Top line results from a phase II trial of AXS-05 for smoking cessation treatment are anticipated in first quarter of 2019. -- Initiate a phase III trial of AXS-07 for the acute treatment of migraine in the fourth quarter of 2018.

4. Replimune Group Inc. (REPL)

Gained 14.58% to close Tuesday's trading at $19.25.

News: No news

Recent event:

The Company listed its IPO on the Nasdaq Global Market on July 19, 2018, at an offering price of $15.00 per share.

Clinical Trials & Near-term Catalysts:

The lead product candidate is RP1.

A phase I/II trial of RP1 alone and in combination with Opdivo in mixed advanced solid tumors in the UK is underway. RP1 in combination with Opdivo is also being explored in the indications of metastatic melanoma, metastatic bladder cancer, microsatellite instability high cancer, and non-melanoma skin cancer, and phase I/II trials are ongoing. The phase II part of the trials is expected to be initiated in the first half of 2019. A phase II clinical trial of RP1 in combination with cemiplimab, versus cemiplimab alone, in cutaneous squamous cell carcinoma is planned for the first half of 2019.

Next up in the pipeline is RP2 for mixed advanced solid tumors, including triple negative breast cancer, which is expected to enter phase I trial in the first half of 2019.

Another product candidate is RP3, which is in early stage of development, and it is expected to enter phase I trial in the first half of 2020.

5. Geron Corporation (GERN)

Gained 14.05% to close Tuesday's trading at $5.52.

News: Investors are optimistic that Janssen, the subsidiary of Johnson & Johnson, will maintain the license rights and continue the development of Imetelstat, and a decision regarding this is expected by the end of the third quarter.

Geron has a deal in place with Janssen, under which Janssen is wholly responsible for the development, manufacturing, seeking regulatory approval for and commercialization of Imetelstat worldwide.

If Janssen takes a positive decision, Geron would receive a $65 million milestone payment at the time of an affirmative Continuation Decision, and would be eligible to receive potential payments of up to $470 million for the achievement of certain development and regulatory milestones, up to $350 million for the achievement of certain sales milestones, and tiered royalties ranging from a mid-teens up to low twenties percentage rate on worldwide net sales of Imetelstat.

Clinical Trials:

-- A phase 2/3 clinical trial of Imetelstat, dubbed IMerge, in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent, is underway. -- A phase II clinical trial evaluating two doses of Imetelstat in intermediate-2 or high-risk myelofibrosis (MF) patients who are refractory to or have relapsed after treatment with a JAK inhibitor, dubbed IMbark, is ongoing.

6. Rigel Pharmaceuticals Inc. (RIGL)

Gained 13.24% to close Tuesday's trading at $3.25.

News: No news

Recent event:

On August 9, the Company reported financial results for the second quarter of 2018. The second quarter of 2018 marked Rigel's pivotal transition to a commercial stage company with the successful launch of TAVALISSE. The drug is approved for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Net loss for the second quarter of 2018 was $25.6 million or $0.16 per share compared to a net loss of $19.1 million or $0.16 per share in the same period of 2017. The net product sales from TAVALISSE were $1.8 million in the recent second quarter compared to nil in the year-ago same period.